Written on: June 1, 2024 by Cassandra Taylor
Your proprietary formula is worth its weight in gold. It is prudent to protect this invaluable information and avoid disclosing specific details on a safety documentation.
In the U.S., it is not uncommon for suppliers to hide chemical information on the safety data sheet (SDS) for a hazardous product as “trade secret.” This is permitted without any registration or administrative fee required, as long the claim can be supported and given that it provides an advantage over competitors who do not know or do not use it. In contrast, it is challenging to obtain approval to withhold chemical information for a mixture in Europe. Under the European Union Classification, Labeling & Packaging (EU CLP) regulation, an approval to use an alternative chemical name can only be obtained for chemicals that do not have any community workplace exposure limits, and that are classified into specified, less severe, hazard categories.
Canada is a middle ground between the relaxed U.S. and the stricter EU confidentiality provisions. In Canada, a registration must be completed to withhold chemical details from the SDS. If you are thinking about hiding confidential chemical information on your Canadian Workplace Hazardous Materials Information System (WHMIS) SDS, you will want to continue reading!
HMIRA background
The Hazardous Materials Information Review Act (HMIRA) and Hazardous Materials Information Review Regulations (HMIRR) set out the requirements for suppliers that wish to claim an exemption from the obligation to disclose confidential business information (CBI) with respect to SDS and labeling requirements under the Hazardous Products Act (HPA) in Canada.
Amendments to HMIRA and HMIRR came into force in 2020 and, since then, Health Canada has been working to modernize the administration of the program to improve efficiencies. There is a new searchable webpage that consolidates claim information, such as exemption status and expiry date, in one location in a user-friendly format.
Health Canada has also updated the online application form to provide an easier, more streamlined claim application process. Once filled out, the application can be submitted, downloaded, and saved as an .hcxs file, which can be uploaded again at a future time if modifications are required.
To withhold the name of a hazardous chemical from the SDS, a generic chemical name (GCN) must be chosen to take its place. Selecting any generic replacement for the chemical name—such as “proprietary chemical 1”—is not allowed. The GCN should be less specific than the true chemical name but no more general than necessary to protect the CBI. It must not convey false or misleading information about the nature of the chemical. Health Canada released a helpful guidance document that explains strategies for developing a GCN along with some specific examples and commonly encountered errors.
New service standards
In the past, registration has been a slow process, sometimes taking Health Canada several years before a HMIRA claim is fully reviewed and accepted. This used to result in large backlogs of mixtures with claims in limbo waiting for approval. In 2023, Health Canada introduced a new multi-staged review process wherein claims are assessed separately from SDS and label compliance. This allows for a more streamlined process for claimants to have up-to-date information on their submissions in a more predictable and timely manner.
Under the new process, once all information needed to complete an evaluation is provided, the registry number (RN) and date of filing are issued together with a claim validity decision or consultation document at the time of registration. The RN must be displayed on the SDS of a hazardous mixture to import or sell the product in Canada without disclosing the CBI. This method results in faster and more predictable responses about the claim status and helps ensure that the three-year exemption period is followed more closely. For the issuance of an RN on up to 15 HMIRA exemption claims, Health Canada has now committed to a service delivery standard of just 10 business days from the date of the receipt of a complete application. The standard for 16–25 claims is 15 business days, and for 26 or more claims, the standard is 20 business days. Health Canada confirmed that it processed 100% of claims for exemption applications within the service standards for fiscal year 2022–2023. The new service standards officially took effect on April 1, 2024.
In our anecdotal experience at Nexreg, we have also found that the response from Health Canada for HMIRA claims has improved substantially. Recently, we have assisted clients with HMIRA submissions and received responses from Government of Canada agents in fewer than two business days.
The fees associated with submitting a HMIRA claim are adjusted on April 1 of each year. The cost is updated in the April Consumer Price Index for Canada, as published by Statistics Canada for the previous fiscal year. Fees can now be paid online via credit card.
2024–2025 work plan & multi-stakeholder workshop
In terms of the next steps for regulatory activities, Health Canada’s Workplace Hazardous Products Program (WHPP) will focus on the following priorities during the 2024–2025 fiscal year:
• Increasing transparency of inspection information
• Publication of additional hazardous substance assessments
• Implementation of the amended Hazardous Products Regulations (HPR)
• Ongoing international leadership
With these priorities in mind, Health Canada aims to strengthen compliance promotion and advance work on key policy files. Additionally, Health Canada is actively participating in United Nations Sub-Committee of Experts on the GHS (UNSCEGHS), and in the Canada–U.S. Regulatory Cooperation Council, to advance global health and safety and facilitate regulatory alignment throughout North America.
Initially planned for this Spring, the 2024 WHPP multi-stakeholder workshop has been rescheduled to Fall 2024. The multi-stakeholder workshop is an opportunity for interested parties to engage with those affected by WHMIS and provide regulators with valuable ideas and feedback. The Government of Canada would like to maximize the usefulness of the workshop by leveraging the availability of more substantive updates coming later this year. As we go to press, there had been no word yet on the update to the U.S. Hazard Communication Standard, which is anticipated to be released soon. The specific timing of the multi-stakeholder workshop has not yet been confirmed. Industry stakeholders and other interested groups are encouraged to lead discussion topics. The deadline to submit topic proposals is July 2, 2024.
Health Canada plans to continue to issue general program updates via the quarterly WHPP newsletter. If you have any questions about Canadian regulatory compliance or trade secret registrations, don’t hesitate to reach out to us at Nexreg Compliance. SPRAY
